Are people with intellectual an developmental disabilities who lack capacity to consent at risk of being excluded from research? Ethical implications of mental (in) capacity legislation in the UK

Introduction: Mental (in)capacity legislation stipulates a specific routefor research ethics review. This paper outlines an exploratory case studythat investigates whether these review requirements lead researchers todecide not to include participants with IDD who lack capacity.

Methods: 20 research ethics committee decision letters werethematically analysed and interviews were conducted with eightresearchers and analysed using grounded theory.

Results: The top three most common themes identified in theresearch ethics committee decision letters were: 1) methodologicalquestions, 2) questions about consent, 3) documentation errors. Fourmain themes were identified from the interviews: 1) lack ofproportionality, 2) con flicting interpretation, 3) bad meeting experience,4) bad outcome.

Implications: Findings suggest that the ethics review process inrelation to assessment of projects that fall within mental (in)capacitylegislation is affecting researchers’ decisions on whether or not to involveparticipants with IDD who lack capacity. This has serious implicationsfor exclusion of this under-researched group from studies from whichthey could benefit.